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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Hyundae Meditech Co., Ltd.
FCRL18100C185
In Commercial Distribution

  • 08800056425176 ()
  • 48800056425174 ()
  • 88800056425172 ()

  • Length: 185 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Determined based on the confidentiality designation assigned to the proprietary brand name associated to the listing number in the Device Registration and Listing Module(DRLM) database. In order to make changes to the Public Release status, please review your confidentiality designation in DRLM.
Hyundae Meditech Co., Ltd.
FCL19100E160
In Commercial Distribution

  • 08800056424223 ()
  • 48800056464227 ()
  • 88800056424229 ()

  • Length: 160 Millimeter


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 3/0(2)70CM DS30 (M)
B BRAUN SURGICAL SA
C0024991
Not in Commercial Distribution

  • 04045439071241 ()
  • 04046963161514 ()

  • Thread Material : polydioxanone
  • Length: 70.00 Centimeter
  • Size of Thread (USP - Others) : 3/0
C0024991

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 0 (3,5)70CM HR26SS(M)
B BRAUN SURGICAL SA
C0024264
Not in Commercial Distribution

  • 04045439071203 ()
  • 04046963161460 ()

  • Size of Thread (USP - Others) : 0
  • Length: 70.00 Centimeter
  • Thread Material : polydioxanone
C0024264

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 3/0 (2)70CM DSMP19(M)
B BRAUN SURGICAL SA
C0024151
Not in Commercial Distribution

  • 04045439071180 ()
  • 04046963161446 ()

  • Thread Material : polydioxanone
  • Size of Thread (USP - Others) : 3/0
  • Length: 70.00 Centimeter
C0024151

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 1 (4) 70CM FR26 (M)
B BRAUN SURGICAL SA
C0024111
Not in Commercial Distribution

  • 04045439071173 ()
  • 04046963161439 ()

  • Length: 70.00 Centimeter
  • Thread Material : polydioxanone
  • Size of Thread (USP - Others) : 1
C0024111

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 0(3.5)140CM HRN65(M)
B BRAUN SURGICAL SA
B0024416
Not in Commercial Distribution

  • 04045439070992 ()
  • 04046963160685 ()

  • Size of Thread (USP - Others) : 0
  • Length: 140.00 Centimeter
  • Thread Material : polydioxanone
B0024416

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 2/0 (3) 120CM PRC24 (M)
B BRAUN SURGICAL SA
C0024850
Not in Commercial Distribution

  • 04045439060368 ()
  • 04046963013981 ()

  • Thread Material : polydioxanone
  • Size of Thread (USP - Others) : 2/0
  • Length: 120.00 Centimeter
C0024850

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 4/0 (1,5) 70CM HR20 (M)
B BRAUN SURGICAL SA
C0024679
Not in Commercial Distribution

  • 04045439060351 ()
  • 04046963013769 ()

  • Length: 70.00 Centimeter
  • Size of Thread (USP - Others) : 4/0
  • Thread Material : polydioxanone
C0024679

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
MONOPLUS VIOLET 3/0 (2) 70CM HR20 (M)
B BRAUN SURGICAL SA
C0024680
Not in Commercial Distribution

  • 04045439060344 ()
  • 04046963013776 ()

  • Size of Thread (USP - Others) : 3/0
  • Thread Material : polydioxanone
  • Length: 70.00 Centimeter
C0024680

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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